Recognized standard
Standard No. 17-1983 (R2014)
FDA recognition 4-130 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-130 |
|---|---|
| Designation | Standard No. 17-1983 (R2014) |
| Title | Denture Base Temporary Relining Resins |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard is for pink and clear powder/liquid auto-polymerizing (self-initiating cure) type hard-setting resins used as temporary relining materials for denture bases. Soft relining materials are not covered by this standard. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: